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Okaybio

by Nanjing Okay Biotechnology Co., Ltd. 2 variants

Ref For Urine 20T, For Oral Fluid/Saliva 10T, For Urine 10T, For Urine 1T, For Oral Fluid/Saliva 20T, For Oral Fluid/Saliva 5T

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978123010074 Basic UDI-DI Date20 Dec 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Ultra Sensitive THC test kit (Colloidal Gold)
Model / Reference
For Urine 20T, For Oral Fluid/Saliva 10T, For Urine 10T, For Urine 1T, For Oral Fluid/Saliva 20T, For Oral Fluid/Saliva 5T
Primary DI / UDI-DI
06978123010074, 06978123010029, 06978123010067, 06978123010043, 06978123010036, 06978123010012
Basic UDI-DI
B-06978123010074, B-06978123010029, B-06978123010067, B-06978123010043, B-06978123010036, B-06978123010012
EMDN Code
W0102160505 Cannabinoids - rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000045561
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Nanjing Okay Biotechnology Co., Ltd.

Properties

  • Reagent

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No